- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01362712
Exploratory, Phase I,Open Label,Non-randomized Study of [F18]CP-18 PET in Normal and Breast Cancer Subjects
May 17, 2012 updated by: Siemens Molecular Imaging
An Exploratory, Phase I, Open Label, Multi-Center, Non-randomized Study of [F18]CP-18 PET in Normal and Breast Cancer Subjects
This trial will be the first trial for the IP, [F-18]CP-18, and will be conducted as an exploratory Phase I trial designed to collect information as this IP is administered and evaluated for the first time in humans.
The trial will evaluate safety, biodistribution and dosimetry data in normal subjects and the trial will evaluate safety, biodistribution and tumor to background imaging data, and correlate image data with caspase 3 activity level on a surgical specimen analyzed by immunohistochemistry in the cancer subjects.
All study results will be evaluated and analyzed in order to consider the design for future clinical trials.
The information collected under this exploratory, Phase I study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management of the subject.
Study Overview
Detailed Description
The Sponsor intends to conduct this exploratory investigation of [F-18]CP-18 in human subjects.
In this study of [F-18]CP-18, it is intended to assess its biodistribution, PET scan resolution, signal to background ratio in tumor, and any adverse events.
This exploratory Phase I study will be used to obtain the necessary safety and dosimetry data in normal subjects and to collect drug biodistribution data, and tumor to background imaging data in breast cancer subjects.
The information collected from this study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management of the subject.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92697-5020
- University of California, Irvine
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
For Normal Volunteers
- Subject is a female or male of any race / ethnicity between 21 to 75 years old at the time of the investigational product administration
- Subject or subject's legally acceptable representative provides written informed consent
- Subject is capable of complying with study procedures
- Subject must have renal functions values as defined by laboratory results within the following ranges:
- Serum creatinine ≤ 2x institutional upper limits of normal
For Cancer Patients
- Patient is a female or male of any race / ethnicity between 21 to 75 years old at the time of the investigational product administration
- Patients or subject's legally acceptable representative provides written informed consent
- Patient is capable of complying with study procedures
- Patient must have renal functions values as defined by laboratory results within the following ranges:
- Serum creatinine ≤ 2x institutional upper limits of normal
- BUN < 2X institutional upper limits of normal
- Patient must have a confirmed diagnosis of stage IIB/IIIA/IIIB, locally advanced breast cancer
- Patient has been or will be scheduled for the surgical resection of tumor(s) after undergoing neoadjuvant treatment and within approximately 7 days following the [F-18]CP-18 PET/CT scan
- Patient has an adequate size breast tumor (≥1.0 cm) that should be amenable to imaging
- Patient's tumor tissue is obtainable following surgery in order to perform immunohistochemistry staining using caspase 3 and/or other apoptosis biomarkers
- Patient must have a previous baseline (pre-neoadjuvant treatment) diagnostic imaging exam including but not limited to MRI, CT, mammography, or [F-18] FDG PET/CT scan that identifies breast tumor location
Exclusion Criteria:
For Normal Volunteers
- Subject is nursing
- Subject is pregnant
- Subject has been involved in an investigative, radioactive research procedure within the past 14 days
- Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality
For Cancer Patients
- Subject is nursing
- Subject is pregnant
- Subject has been involved in an investigative, radioactive research procedure within the past 14 days
- Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality
- Patient tumor tissue(s) is not obtainable after tumor resection for caspase 3 and/or other biomarker immunohistochemistry assays
- Patient has had or will have treatment intervention(s) between the [F-18]CP-18 PET/CT scan and tumor resection
- Patient has a history or current evidence of any condition, therapy, lab abnormality that, in the opinion of the study investigator or treating physicians might confound the results of the study or poses an additional risk to the patients by their participation in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To collect biodistribution, dosimetry and metabolite profile of [F-18]CP-18 from normal subjects
Time Frame: Visit 2 and Visit 3
|
Visit 2 and Visit 3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To collect pre-dose and post-dose parameters of vital signs, ECG and CBC and clinical chemistry data along with monitoring any adverse events of the IP from normal and cancer subjects.
Time Frame: Visit 2 and Visit 3
|
Visit 2 and Visit 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Edward Aten, MD, President, Certus International Inc. Medical Monitor
- Principal Investigator: Michael Yu, MD, FCCC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
May 13, 2011
First Submitted That Met QC Criteria
May 26, 2011
First Posted (Estimate)
May 30, 2011
Study Record Updates
Last Update Posted (Estimate)
May 21, 2012
Last Update Submitted That Met QC Criteria
May 17, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-18 100
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
Clinical Trials on [F18]CP-18 Injection
-
Avid RadiopharmaceuticalsTerminatedAlzheimers DiseaseUnited States
-
Avid RadiopharmaceuticalsTerminatedAlzheimers Disease | ADUnited States
-
Avid RadiopharmaceuticalsCompleted
-
Avid RadiopharmaceuticalsCompleted
-
Avid RadiopharmaceuticalsCompleted
-
Mayo ClinicWithdrawnBreast NeoplasmUnited States
-
Avid RadiopharmaceuticalsCompleted
-
Avid RadiopharmaceuticalsCompletedAlzheimer DiseaseUnited States
-
Avid RadiopharmaceuticalsTerminated
-
Avid RadiopharmaceuticalsCompletedAlzheimer Disease | Mild Cognitive Impairment